Objectives: Our working hypothesis is that patients who opt in to pharmacist counseling will have a higher medication possession ratio and longer length on therapy than patients who opt out of pharmacist counseling. Methods: Using data extracted from patient’s charts we retrospectively calculated medication possession ratio and length on therapy in relation to the patient receiving or not receiving counseling. Results: The patients analyzed were receiving 8 specific oral oncolytic medications provided by Avella Specialty Pharmacy in 2015. There were no significant differences found in MPR values for any of the 8 oral oncolytic medications included in the study. Iressa (p=0.826), Lonsurf (p=0.392), Stivarga (p=0.838), Zydelig (p=0.633), Zykadia (p=0.077), Tagrisso (p=0.060), Imbruvica (p=0.263) and Tarceva (p=0.326). No statistically significant differences were found in LOT values for any of the 8 oral oncolytic medications included in the study. Iressa (p=0.885), Lonsurf (p=0.868), Stivarga (p=0.326), Zydelig (p=0.502), Zykadia (p=0.212), Tagrisso (p=0.089), Imbruvica (p=0.540), Tarceva (p=0.129). Conclusions: Pharmacist counseling does not appear to affect MPR or LOT for patients taking oral oncolytic medications. Further research is warranted targeting other chronic disease states with complex oral regimens where medication adherence has not already been established from prior therapy options and adequate disease state knowledge.

Objectives: In this paper we analyzed the time frame for oncology drugs that were designated as a fast track drug and the time transition from a phase II to phase III clinical trial completion. Methods In our study we utilized oncology drugs that were approved between the years of 2000-2006 (FDA.gov). We then analyzed the CDER data base that provided information to Fast Track drugs that have been approved within the time period as determined by the FDA selection criteria (21 CFR 312.81(a)). Under certain circumstances, the FCA may consider reviewing portions of a marketing application in advance of the complete New Drug Application (NDA) or Biologic License Application (BLA). We will evaluate fast track designated products which may also be eligible to participate in FDA’s Continuous Marketing Applications Pilot 1 or Pilot 2 programs. For our analysis, we specifically selected oncology drugs. In particular, we analyzed 32 drugs from the stated time period. Each fast track drug was then selected and analyzed for its clinical phase development time period based on news announcements during clinical trails. For each announcement we conducted an event study analysis through lexis Nexus with respect to the announcement of a clinical trial enrollment, clinical trials news (Phase I, II, III). Results: The results of our preliminary study show that there was a shorter time to development transition for the fast track oncology drugs. The oncology clinical phase transition from II to three on average lasted 12 months with a range of 2 - 29 months The average length of the phase development had to excludes 4 drugs due to the lack of information provided from the LexisNexis database. The current timeline for fats track drugs has shown a decrease in transition from clinical trials to the market. In the example of Spyrcel, the data from our study had to be excluded, there was a definitive difference in the time to approval process for the drug as compared to other standard review entities. The approvals for dasatinib, or Sprycel, for refractory CML was shown to move through the development to approval in one of the fastest timeframes in modern development. Since its first clinical study on in Gleevec-resistant patients, the medication was decided on entering an accelerated timeline. It took us just 25 months to bring Sprycel from first-in-human dosing to a regulatory submission. In contrast, the industry average for this cycle time is 6.4 years which is three times greater than the cycle time for Sprycel. Conclusions: The new Subpart H regulations state that post-marketing studies to confirm clinical benefit that would consist usually by "studies underway” at the time of accelerated approval, this has not always been the case and is not a requirement (Dagher R, Johnson J, Williams G et al). In conclusion, the accelerated approval program in oncology has been successful in making 18 different products available to patients for 22 different cancer treatment indications since the inception of the fast track program. From the current data and transition information, there is a comparative difference between the clinical phase transitions from phase II to Phase III clinical trials. However, this preliminary data needs to be further evaluated against the standard FDA review process from oncology drugs. Moreover, further studies will be needed to interpret whether the average length of oncology studies biases the value of our study.

Objectives: Milk protein allergy is estimated to affect 1.2% to as much as 17% of people of all ages. Advair® Diskus® (FP/SX) utilizes lactose as an excipient which limits the utility of this product for this population. Furthermore, Advair® Diskus® is formulated as an interactive physical mixture via a micronization process. Alternatively, spray dried engineering achieves narrow particle size distribution, allowing greater deposition in the targeted respiratory bronchioles. The purpose of this dry powder inhaler (DPI) study was to conduct an in vitro comparative analysis of the aerodynamic performance of a co-spray dried lactose-free formulation of FP/SX with a mannitol excipient as a molecular mixture versus the Advair® Diskus® 250/50 (FP/SX) interactive physical mixture product. Methods: Utilizing mannitol as an excipient, a co-spray dried FP/SX powder was prepared using the Buchi Mini-Spray Dryer B-290 under closed system configuration. The resulting feed solution was spray dried at pump rates of 25%, 50%, and 100% with all other parameters remaining constant (aspiration, atomization rate, nitrogen gas rate). The primary outcome measure, aerodynamic performance, was assessed using the Copley Next-Generation Impactor (NGI). NGI data for the DPIs was used to calculate mass median aerodynamic diameter (MMAD), geometric standard deviation (GSD), and fine particle fraction (FPF) of each powder, including the Advair® Diskus®. Residual water content was quantified by Karl Fischer titration. Particle characteristics were visualized by scanning electron microscopy. Results: FPF, MMAD, and GSD were calculated from NGI data; Wolfram Alpha software was used to calculate MMAD and GSD. T-test regression was used for comparative analysis of spray-dried and Advair® Diskus® powders. MMAD for each spray dried sample was analyzed using a t-test regression against the MMAD values from the Advair® Diskus®. Using aerodynamic analysis studies triplicated for each powder, there was no significant difference between the spray dried powder and Advair® Diskus® for MMAD and GSD (p-values >0.05). The 50% and 100% pump rate samples had similar FPF to the Advair® Diskus® (p-values >0.05). However, the 25% pump rate sample had a significantly improved FPF compared to the Advair® Diskus® (p <0.01). Conclusions: A co-spray-dried lactose-free formulation of FP/SX with a mannitol excipient demonstrated similar aerodynamic performance to the Advair® Diskus® which consists of a physical mixture of two drugs with lactose. Of significance, 25% pump rate spray-dry conditions demonstrated an improved FPF compared to the Advair® Diskus®.

Objectives: The objective of this retrospective cohort chart review was to evaluate the safety and efficacy of extended infusion beta-lactam regimens as part of treatment of acute CF pulmonary exacerbations in adults and pediatric patients. Methods: Inclusion criteria: adult and pediatric patients (age 1 month or older) with CF diagnosis who were admitted to BUMC-T for acute pulmonary CF exacerbation, and who received meropenem, imipenem, aztreonam, piperacillin-tazobactam, and or cefepime during their hospitalization (between 1/1/2011 and 10/30/2015). Exclusion criteria: pregnant women and admissions less than 24 hours. The two groups evaluated were patients receiving treatment (group 1) prior to extend infusion practices (Jan 2011 – Dec 2012) and (group 2) after implementation of extend infusion practices (Jan 2013 – Oct 2015). Data was collected from medical records using both the Sunrise Clinical Manager and EPIC electronic medical record systems. The data was then analyzed for differences in efficacy outcomes (e.g., length of hospitalization, lung function, return to baseline lung function), changes in renal and hepatic function, incidence of documented adverse drug effects, and potential factors associated with increased risk for changes in renal or hepatic function with use of extended infusion beta‐lactam regimens. Results: Pending. Efficacy outcomes: - length of hospitalization - improvement in lung function - return to baseline lung function Safety outcomes: - changes in renal and hepatic function - incidence of documented adverse drug effects - potential factors associated with increased risk for changes in renal or hepatic function Conclusions: Pending. As this study is being conducted at one academic medical center, conclusions may not be generalizable to other institutions.

Part II: Biosafety and Environmental Health Program Implementation Related to Manufacturing and Research of Medical Diagnostic Systems Focusing on Biopsy-Based Cancer Tests and Reagents / Abstract: Occupational and environmental health and safety are essential factors in the public health field. One’s occupation is the central activity for adults, a means to earn an income, and a center for the advancement of society. Safety in the workplace not only provides a secure environment for the employee, but it also reduces costs for the employer over time by diminishing work related injuries, illnesses and lost work time and production delays. Occupational health in turn plays a unique and important part in the environmental health as well. With improved health and safety in a workplace, workers are more conscience of how the hazardous material they dispose of affects themselves as well as their environmental surroundings. It is our duty as inhabitants of this planet, to protect our environmental surrounds. By understanding our ecological footprint contributed by daily work activities we can begin to improve our environmental health. In order to accomplish these goals health and safety programs specific to the occupation and local environmental concerns are necessary. Ventana Medical Systems Inc, is a cancer diagnostics company that specializes in the development and manufacture of primary stain, special stain, Immunohistochemistry (IHC), and in situ hybridization (ISH) staining platforms and reagents. These reagents and platforms are used in hospitals, clinical labs, and research facilities all over the world to diagnose and determine the proper treatment for specific cancers. With such high stakes resting on the quality and production of reagents and staining platforms, employee health and safety is crucial to maintain production of reliable products to customers. In response the Safety, Health and Environmental (SHE) department at Ventana is currently employing several different occupational and environmental health programs. Thus for my internship project I participated in compiling waste profiles, performing laboratory audits/walk-throughs, assisting with waste water and storm water profiling, and participating in risk assessments by attending risk assessment meetings and providing feedback. By setting these improved programs into place, SHE at Ventana can ensure that employees become acclimated to safety and health guidelines. Ventana Medical Systems Inc., has already shown progress in reducing waste by recycling, and increasing productivity by reducing employee injury in incident prone work areas. These programs will allow employees to conduct their research and manufacturing in safer and healthier work environments, as well as ensure that the company maintains its goals of improving the impact of business on the environment.

Objectives: The purpose of this study is to determine if an antibiotic formulary is beneficial in an inpatient ICU setting. The main goal, of course, is to ensure patients receive the most appropriate antimicrobial therapy resulting in the least amount of resistance, by using an antibiotic formulary and ICU antibiotic intervention. Methods: This project will use a retrospective design in which one-year post-intervention antibiotic resistant trends will be compared with pre-intervention trends at Yuma Regional Medical Center (YRMC). As is common at YRMC, patients started on antibiotic therapy had susceptibility testing performed to determine the best treatment for the patient. This susceptibility data will be the data used for comparison. Comparison of patient charges and hospital costs associated with these patients will also be performed. YRMC employed an ICU antibiotic intervention documentation form that was used to monitor and extrapolate intervention data. Hospital lab percent susceptibility data will be looked at to determine isolate susceptibility data to determine if any trends are present in antibiotic resistance between the time period when the antibiotic formulary was implemented and the previous corresponding period of time before the formulary. This data will also be compared with the hospital trends in resistant isolates as a whole. The data is desensitized, as individual patient data is not being reviewed. In looking at patient charges and hospital costs, charts will be reviewed. These charts will be de-identified to the investigators of this study. Of further note, YRMC placed the intervention in action in February 2006 and began collecting post-intervention data at that time. This study will be using post intervention data collected from February 2006 thru February 2007. Results: Conclusions:

Objectives: To assess the cost-effectiveness of vancomycin, daptomycin, linezolid, oritavancin, and telavancin as empiric treatment for MRSA skin and soft tissue infections in an inpatient setting from a third party perspective. Methods: A decision analytic tree model was constructed using TreeAge Pro and utilizing efficacy data from published clinical trials and costs estimates using HCUPnet.gov and Micromedex’s RedBook. Sensitivity analyses were run on linezolid costs, as well as oritavancin’s costs and efficacy data. Results: Linezolid was the most cost effective medication, dominating all other therapies. In a sensitivity analysis, increasing linezolid’s cost to include 7 days of inpatient therapy did not result in other therapies no longer being dominated. In two other sensitivity analyses, oritavancin was no longer dominated at 91.8% efficacy, but was still dominated with only 3 days of inpatient therapy. Conclusions: Linezolid was the most cost effective therapy for empiric treatment of suspected MRSA skin and soft tissue infections requiring hospitalization from a third party perspective.

OBJECTIVES: To compare possible differences in the proportion of serious potential ADEs associated with high-risk medications that were avoided by the use of AID technology in adult and pediatric ICU patients and to investigate the proportion of serious ADEs associated with high-risk medications as identified by root cause analyses (RCA) that occurred before and after AID implementation. METHODS: Study Site: This retrospective study was conducted at a tertiary care, academic medical center in Tucson Arizona. Design: This was a two-part retrospective study involving data obtained from an AID database and root-cause analyses. Information on high-risk medications obtained from the AID database was used to compare the proportion of serious ADEs avoided by the use of AID technology in adult and pediatric patients. Information on high-risk medications (administered by continuous infusion) obtained from root-cause analyses was used to compare the proportion of serious ADEs that occurred during the 5-year period before and the 5-year period after AID implementation. RESULTS: A total of 261 infusions (225 in the adult and 36 in the pediatric) generated an alert where the final outcome resulted in a reprogramming event when the limit was exceeded by 2.5 times or greater. The pediatric population was 1.68 time (95% CI=1.18 to 2.38) more likely to require a reprogramming event than the adult acute care population for all high-risk medications combined. Significantly more reprogramming events occurred in the pediatric patients with potassium (RR=2.77, 95 CI=1.15 to 6.68) and insulin (RR=2.73, 95% CI=1.15 to 6.45) infusions. Overrides accounted for 80% of the total reprogramming and override events when the maximum limit was exceeded by 10 times or more. There were significantly more overrides in the pediatric compared to the adult population for the high-risk medications (RR=1.82, 95% CI=1.32 to 2.53), however, there were significantly fewer overrides in the pediatric versus adult patients on fentanyl (RR=0.34, 95% CI=0.17 to 0.70). CONCLUSIONS: We found that medication errors involving high-risk medications with the potential to cause ADEs can occur frequently during the administration phase of drug delivery. While smart AIDs cannot intercept all errors, it did show that it was able to intercept certain errors, especially key=pad entry errors. We also determined that when an alert was generated involving our high-risk medications, clinicians were more apt to reprogram the AID when the alert occurred in our pediatric population. While smart pumps have shown great improvement and allow for safer drug delivery, more research is needed in this area before the ability of these smart AIDs to improve drug administration safety can be shown.

Objectives: To determine the cost-effectiveness of proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors with high-intensity statins compared to high-intensity statins alone for the treatment of heterozygous familial hypercholesterolemia (HeFH). Methods: A Markov model was built through TreeAge Pro to model two groups: patients taking PCSK9 inhibitors with high-intensity statins or high-intensity statins alone. For each group, there were five health states that patients could be in: well, unstable angina, myocardial infarction, ischemic stroke, or death. The data used in the model were extracted from published clinical trials evaluating PCSK9 inhibitors and statins. Results: For the primary analysis, the overall cost and effectiveness was $31,390.93 and 23.01 for the statin alone group and $362,798.50 and 24.32 for the PCSK9 with statin group, respectively. The incremental cost, incremental QALY, and incremental cost-effectiveness ratio (ICER) was $331,407.60, 1.31 QALYs, and $252,833.60/QALY, respectively. Conclusions: Since the calculated ICER was higher than the pre-established threshold of $150,000, the results from our primary analysis suggest that treatment of patients with HeFH with a PCSK9 inhibitor and a high-intensity statin is not cost effective, compared to treatment with a high-intensity statin alone. However, when certain parameters (cost of PSCK9 and mortality rate) were adjusted in the secondary analyses, these agents appear to be cost-effective.

Urbanization in China is rapidly improving with the economic growth. But the development that ignores environment has caused lots of environmental problems in Chinese cities, especially the large ones. As the capital of Hubei Province, Wuhan is the fifth among China cities for its size and its economic production. Because of extreme urbanization and high dense population in Wuhan city, some significant issues have been constantly emerged: lack of adequate wastewater management and water resources protection, urgent need for efficient solution to sludge treatment and disposal, serious urban flooding because of the natural flow or urban lakes and streams restriction, degradation of water quality, and so on. These issues have been seriously impacted the quality life in the city. Along with the urbanization, the conflicts between urban development and ecosystem are inescapable. How can urban development balance environmental sensitivity to support ecological health in the vulnerable urban ecosystem and mitigate the problems in the city? This project tries to redesign a master plan for Yangchun Lake sub-urban center in Wuhan city and find suitable ways to mitigate these problems with attention to the environmental, functional, economic, social and aesthetics aspects of the proposed solutions. The design will balance the urban development and environmental protection, support and enhance the development of a new ecological urban center.

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